Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12615000979550
Ethics application status
Approved
Date submitted
2/09/2015
Date registered
18/09/2015
Date last updated
23/11/2018
Date data sharing statement initially provided
23/11/2018
Date results information initially provided
23/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Training in interaction, communication and Literacy (TICL): Effects of a 10 week professional development program on early childhood educators and the children they teach.
Scientific title
Training in interaction, communication and Literacy: Effects of a 10 week professional development program for early childhood educators on their skills and knowledge and on the language and early literacy skills of the preschoolers they teach
Secondary ID [1] 287402 0
Nil
Universal Trial Number (UTN)
U1111-1173-9236
Trial acronym
TICL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Language and literacy skills in preschool-aged children 296107 0
Condition category
Condition code
Public Health 296363 296363 0 0
Health promotion/education
Physical Medicine / Rehabilitation 296421 296421 0 0
Speech therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A 10 week professional development program will be delivered to early childhood educators by speech pathologists. The program is known as the Training in Interaction, Communication and Literacy (TICL) program and aims to improve the language and early literacy skills of children by up-skilling their educators.

The TICL program covers the following skill areas known to facilitate improved language and literacy skills in preschool-aged children (El-Choueifati, McCabe, Munro, & Purcell, 2008; El-Choueifati, Purcell, McCabe, & Munro, 2012);
*Developing positive and responsive adult and child interactions
*Explicit literacy instruction
*Developing storytelling skills
*Encouraging all children in a group to participate
*Fostering peer to peer interactions
*Developing responsive family involvement in language and literacy

The program includes 1x1 hour small group workshops and 1x1 hour coaching sessions facilitated face-to-face by a speech pathologist. These sessions occur once a week for 10 weeks.

El-Choueifati, N., McCabe, P., Munro, N., & Purcell, A. (2008). What do early childhood workers want from speech pathology based professional development activities?

El-Choueifati, N., Purcell, A., McCabe, P., & Munro, N. (2012). Evidence-based practice in speech language pathologist training of early childhood professionals. Evidence-Based Communication Assessment and Intervention, 6(3), 150-165. doi:10.1080/17489539.2012.745293
Intervention code [1] 292755 0
Other interventions
Comparator / control treatment
The control group receives no intervention
Control group
Active

Outcomes
Primary outcome [1] 296012 0
The language and early literacy skills of preschoolers (composite outcome)
*Overall language abilities: Clinical Evaluation of Language Fundamentals Preschool-Second Edition CELF P-2 , Australian and New Zealand Standardised Edition (Wiig et al., 2006). (15-20 minutes)
*Overall early literacy abilities: Comprehensive Test of Phonological Processing, Second Edition CTOPP-2, a standardised assessment (Wagner et al., 2013). (15-20 minutes)
*Expressive vocabulary: Expressive One-Word Picture Vocabulary Test – Fourth Edition EOWPVT-4, the assessment is standardised (Gardner, 1979).(15 minutes)
*Receptive Vocabulary: Peabody Picture Vocabulary Test, Fourth Edition PPVT-4 (Dunn & Dunn, 2012). (10 minutes)
*Storytelling understanding and use will be evaluated using a narrative retell. The preschoolers will be told a short story with pictures and then, using the pictures as prompts, they will be asked to retell it. Their story will be transcribed and then analysed for sentence length, use of story grammar and use of sophisticated vocabulary. This is a descriptive assessment. (10 minutes)
*Oral language and literacy: The Teacher Rating of Oral Language and Literacy TROLL (Dickinson et al., 2001), a standardised assessment to be completed by an ECE. (10 minutes)
Timepoint [1] 296012 0
6 months post intervention completion
Secondary outcome [1] 317228 0
Changes in skills and knowledge of the early childhood educators (composite outcome) as measured by;
*The Interaction, Communication and Literacy ICL skills audit (El-Choueifati et al., 2014) (30 minutes)
*The Early Language Literacy and Classroom Observation Pre-Kindergarten ELLCO Pre-K (Smith, Brady, & Anastasopoulos, 2008). (20 minutes)
Timepoint [1] 317228 0
immediately post intervention and at 6 months post intervention completion
Secondary outcome [2] 317229 0
The language and early literacy skills of preschoolers (composite outcome)
*Overall language abilities: Clinical Evaluation of Language Fundamentals Preschool-Second Edition CELF P-2 , Australian and New Zealand Standardised Edition (Wiig et al., 2006). (15-20 minutes)
*Overall early literacy abilities: Comprehensive Test of Phonological Processing, Second Edition CTOPP-2, a standardised assessment (Wagner et al., 2013). (15-20 minutes)
*Expressive vocabulary: Expressive One-Word Picture Vocabulary Test – Fourth Edition EOWPVT-4, the assessment is standardised (Gardner, 1979).(15 minutes)
*Receptive Vocabulary: Peabody Picture Vocabulary Test, Fourth Edition PPVT-4 (Dunn & Dunn, 2012). (10 minutes)
*Storytelling understanding and use will be evaluated using a narrative retell. The preschoolers will be told a short story with pictures and then, using the pictures as prompts, they will be asked to retell it. Their story will be transcribed and then analysed for sentence length, use of story grammar and use of sophisticated vocabulary. This is a descriptive assessment. (10 minutes)
*Oral language and literacy: The Teacher Rating of Oral Language and Literacy TROLL (Dickinson et al., 2001), a standardised assessment to be completed by an ECE. (10 minutes)
Timepoint [2] 317229 0
12 months post intervention completion

Eligibility
Key inclusion criteria
Early childhood educators must work at the preschool/childcare centres recruited into the study and provide informed consent in order to be included in the study. They must also be able to attend on the days that the TICL program is delivered.
Preschoolers must attend one of the preschool/childcare centres recruited into the study and their parents/carers must have provided informed consent.
Minimum age
3 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
There are no exclusion criteria

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
This is a cluster-randomised trial. Preschool/childcare centres will be recruited via a community organisation and then individuals will be provided with information about the trial and offered the chance to participate (early childhood educators and children via their parents). 50% of preschools will be allocated to receive the treatment and 50% will act as controls. This random allocation will be done by a University of Sydney researcher who is independent and blind to the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random number sequence in opaque envelopes using permuted block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis
Sample Size Calculation:
Preschoolers
- An effective sample size was determined using a power analysis, with power =0.80, an effect size of 0.5 and a significance level of 0.05 using G*Power (Faul, Erdfelder, Lang, & Buchner, 2007). The results indicated that an effective sample size of 128 preschoolers in total would be required; 64 preschoolers in the TICL group and 64 in the control group.
- Next, an intracluster correlation coefficient (ICC) of 0.0138 was calculated based on pilot research.
- We then calculated the minimum number or preschoolers required if we recruited 4 or 6 preschools/clusters (based on realistic resources) and ascertained that we would need 57 preschoolers from 4 preschools or 30 preschoolers from 6 clusters.
- Finally, a decision was made to recruit 6 preschools based on the more realistic number of preschoolers in each cluster required to get an effective sample size of 128.
- Based on pilot research we also predict that there will be a 12% attrition rate. Taking this into account, we believe that aiming for an average of 35 preschoolers from each preschool/child care centre will allow for a natural attrition of up to 12% with enough power to still show a medium effect. Additionally, we believe that 35 preschoolers from each preschool/child care centres is a realistic number.

Early childhood educators
- The intended sample size is 24 based on the above sample size of preschoolers. Currently the required ratio of early childhood educator to child is 1:11 for children aged 36 months and over (http://www.careforkids.com.au/articlesv2/article.asp?ID=127). Therefore we expect 4 early childhood educators to be recruited with each group of 35 preschoolers from each of the six preschools/child care centres. We are unable to conduct a power analysis on this group of participants and their outcomes are secondary in the project.

Preschool/childcare centres

-Based on the above sample size of preschoolers, 6 preschool/childcare centres will be recruited.

Preschooler and ECE data will be analysed using a series of 2 (group) x 4 (times) factorial Analyses of Variance (ANOVA) nested by preschool with repeated measures on the second factor."

Faul, F., Erdfelder, E., Lang, A.-G., & Buchner, A. (2007). G*Power 3: A flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behavior Research Methods, 39(2), 175-191. doi:10.3758/BF03193146

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
21/09/2015
Actual
1/12/2016
Date of last participant enrolment
Anticipated
29/01/2016
Actual
2/10/2017
Date of last data collection
Anticipated
Actual
1/03/2018
Sample size
Target
234
Accrual to date
Final
115
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 291967 0
Government body
Name [1] 291967 0
Communities for Children via the Department of Social Services
Country [1] 291967 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
The University of Sydney
NSW 2006 AUSTRALIA
Country
Australia
Secondary sponsor category [1] 290636 0
None
Name [1] 290636 0
Address [1] 290636 0
Country [1] 290636 0
Other collaborator category [1] 278607 0
Charities/Societies/Foundations
Name [1] 278607 0
Bankstown Community Resource Group
Address [1] 278607 0
BCRG 15 Kitchener Parade, Bankstown NSW 2200
Country [1] 278607 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293464 0
University of Sydney
Ethics committee address [1] 293464 0
The University of Sydney
NSW 2006 AUSTRALIA
Ethics committee country [1] 293464 0
Australia
Date submitted for ethics approval [1] 293464 0
03/09/2015
Approval date [1] 293464 0
11/09/2015
Ethics approval number [1] 293464 0
2015/676

Summary
Brief summary
This project will evaluate the Training in Interaction, Communication and Literacy (TICL) program through a cluster randomised trial. TICL is a 10 week professional development program for Early Childhood Educators (ECEs), delivered by Speech Pathologists, and designed to improve the language and early literacy skills of preschoolers. Pre and post measures of changes in the knowledge and skills of ECEs and the language and literacy skills of the preschoolers they care for will be taken. These results will be compared with a control group of ECEs and preschoolers. We hypothesise that TICL will improve the language and early literacy skills of preschoolers when compared with no treatment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 60030 0
Dr Alison Purcell
Address 60030 0
Room S167
Cumberland Campus - East St
The University of Sydney
Lidcombe, NSW 2141
Country 60030 0
Australia
Phone 60030 0
+61 2 9351 9335
Fax 60030 0
Email 60030 0
[email protected]
Contact person for public queries
Name 60031 0
Ms Lauren Chaitow
Address 60031 0
Room S164
Cumberland Campus - East St
The University of Sydney
Lidcombe, NSW 2141
Country 60031 0
Australia
Phone 60031 0
+61427610110
Fax 60031 0
Email 60031 0
[email protected]
Contact person for scientific queries
Name 60032 0
Dr Alison Purcell
Address 60032 0
Room S167
Cumberland Campus - East St
The University of Sydney
Lidcombe, NSW 2141
Country 60032 0
Australia
Phone 60032 0
+61 2 9351 9335
Fax 60032 0
Email 60032 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The participants were informed that data would only be available to the researchers associated with the study and in published forms


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.